A. Positions and Honors.

Transcription

1 BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME Eron, Joseph J., Jr. era COMMONS USER NAME POSITION TITLE Associate Professor of Medicine EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDY State University of New York, Binghamton, NY B.S Biochemistry Harvard Medical School, Boston, MA M.D Medicine Harvard Medical School, Boston, MA Residencey Internal Medicine Harvard Medical School, Boston, MA Fellowship Infectious Diseases A. Positions and Honors. Employment Director of Internal Medicine, Zuni Indian Health Service Hospital, Zuni, New Mexico Assistant Professor of Medicine, School of Medicine, Infectious Diseases, UNC-CH Associate Professor of Medicine, School of Medicine, Infectious Diseases, UNC-CH 2005-Present Professor of Medicine, School of Medicine, Infectious Diseases, UNC-CH Other Experiences and Professional Memberships: Director of Clinic, Division of Infectious Diseases, UNC-CH Co-Principal Investigator, AIDS Clinical Research Group, UNC-CH Member, ACTG Phase I - II Primary Infection Working Group, ACTG, NIAID Member, HIV Disease Research Agenda Committee, AIDS Clinical Trials Group, NIAID 1995-Present Associate Director, General Clinical Research Unit, UNC-CH 1998-Present Director, Clinical Core, UNC Center for AIDS Research, UNC-CH 2001-Present Principle Investigator AIDS Clinical Research Group, UNC-CH 2001-Present Member, HIV Disease Research Agenda Committee, AIDS Clinical Trials Group, NIAID Vice Chair, HIV Research Advisory Committee, AIDS Clinical Trials Group, NIAID 2002-Present Chair, Data Safety Monitoring Board, TMC-125 Protocol, AIDS Clinical Trials Group, NIAID 2004-Present Chair, HIV Research Advisory Committee, AIDS Clinical Trials Group, NIAID 2004-Present Member, Scientific Agenda Steering Committee, AIDS Clinical Trials Group, NIAID 2006-Present Chairperson of the AIDS Research Review Committee (AIDSRRC), NIAID Honors and Awards: 1994 Medicine Housestaff Teaching Award at University of North Carolina, Chapel Hill 1995 UNC-CH Junior Faculty Development Award, 2000 Alpha Omega Alpha, Medical Honor Society, (nominated by UNC Medical Students) 2005 UNC-CH Distinguished Teaching Award for Post-Baccalaureate Instruction B. Selected peer-reviewed publications (in chronological order). Yeh RF, Gaver VE, Patterson KB, Rezk NL, Baxter-Meheux F, Blake MJ, Eron JJ Jr, Klein CE, Rublein JC, Kashuba AD. Lopinavir/ritonavir induces the hepatic activity of cytochrome P450 enzymes CYP2C9, CYP2C19, and CYP1A2 but inhibits the hepatic and intestinal activity of CYP3A as measured by a phenotyping drug cocktail in healthy volunteers. J Acquir Immune Defic Syndr May;42(1): Thompson MA, Kessler HA, Eron JJ, Jacobson JM, Adda N, Shen G, Zong J, Harris J, Moxham C, Rousseau FS and DAPD-101 Study Group. Short-term safety and pharmacodynamics of amdoxovir in HIV-infected patients. AIDS 2005, 19: PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page Biographical Sketch Format Page

2 Hammer SM, Vaida F, Bennett KK, Holohan MK, Sheiner L, Eron JJ, et al, for the AIDS Clinical Trials Group (ACTG) 398 Study Team. Dual vs. Single Protease Inhibitor Therapy Following Antiretroviral Treatment Failure: A Randomized Trial. JAMA 288(2) 2002: Pilcher CD, McPherson JT, Leone PA, Smurzynski M, et al, Eron JJ, et al. Real-Time, Universal Screening for Acute HIV Infection in a Routine HIV Counseling and Testing Population. JAMA 288(2) 2002: Garba ML, Pilcher CD, Bingham AL, Eron JJ, Frelinger JA. HIV Antigens Can Induce TGF-Beta (1)-Producing Immunoregulatory CD8+ T Cells. J Immunol 168(5) 2002: Freel SA, Fiscus SA, Pilcher CD, et al, Eron JJ, et al. Envelope Diversity, Coreceptor Usage, and Syncytium- Inducing Phenotype of HIV-1 Variants in Saliva and Blood During Primary Infection. AIDS 17(14)2003: Lalezari JP, Eron JJ, Carlson M, Cohen C, DeJesus E, et al. A Phase II Clinical Study of the Long-Term Safety and Antiviral Activity of Enfuvirtide-Based Antiretroviral Therapy. AIDS 17(5) 2003: Kilby JM, Lalezari JP, Eron JJ, Carlson M, Cohen C, Arduino RC, et al. The Safety, Plasma Pharmacokinetics, and Antiviral Activity of Subcutaneous Enfuvirtide (T-20), a Peptide Inhibitor of gp41- Mediated Virus Fusion, in HIV Infected Adults. AIDS Res Hum Retroviruses 19(1) 2003: 83. Lalezari JP, Henry K, O Hearn M, Montaner JS, Piliero PJ, et al, Eron JJ, et al. Enfuvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America. NEJM 348(22) 2003: Kilby JM, Eron JJ Novel Therapies Based on Mechanisms of HIV-1 Cell Entry. NEJM 3487(22)2003: Fischl MA, Ribaudo HJ, Collier AC, Erice A, et al, Eron JJ, et al, for the AIDS Clinical Trials Group 388 Study Team. A Randomized Trial of Two Different Four-Drug Antiretroviral Regimens vs. a Three-Drug Regimen in Advanced Human Immunodeficiency Virus Disease. J Infect Dis 188(5) 2003: Weintrob AC, Giner J, Menezes P, et al, Eron JJ, et al. Infrequent Diagnosis of Primary HIV Infection: Missed Opportunities in Acute Care Settings. Arch Intern Med 163(17) 2003: Gulick RM, Meibohm A, Havlir D, Eron JJ, et al. Six-Year Follow-up of HIV-1-Infected Adults in a Clinical Trial of Antiretroviral Therapy With Indinavir, Zidovudine, and Lamivudine. AIDS 17(16) 2003: Hammer SM, Bassett R, Squires KE, Fischl MA, et al, Eron JJ, et al, for the ACTG 372B/D Study Team. A Randomized Trial of Nelfinavir and Abacavir in Combination With Efavirenz and Adefovir Dipivoxil in HIV-1 Infected Persons With Virologic Failure Receiving Indinavir. Antiviral Therapy 8(6) 2003: Wood R, Arasteh K, Stellbrink HJ, Teofilo E, Raffi F, et al, Eron JJ, et al. A Six-Week Randomised Controlled Trial to Compare the Tolerability, Pharmacokinetics, and Antiviral Activity of GW and Amprenavir in HIV-1-Infected Patients. Antimicrob Agents Chemother 2004 Jan;48(1): Pilcher CD, Price MA, Hoffman IF, Martinson FE, Kazembe PN, Eron JJ, et al. Frequent Detection of Acute Primary HIV Infection in Men in Malawi. AIDS Feb 20;18(3): Hicks CB, King MS, Gulick RM, White AC, Eron JJ, et al. Long-Term Safety & Durable Antiretroviral Activity of Lopinavir/Ritonavir in Treatment-Naïve Patients: Four-Year Follow-up Study M AIDS ;18(5): Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest Apr;113(7): Conradie F, Sanne IM, Venter WD, Eron JJ. Failure of Lopinavir-Ritonavir (Kaletra) Containing Regimen in an Antiretroviral Naïve Patient. AIDS 2004 Apr 30;18(7): Pilcher CD, Tien CH, Eron JJ, Vernazza PL, Leu SY, et al, the QUEST Primary HIV Infection Study Group. Brief but efficient: acute HIV infection and the sexual transmission of HIV. J Infect Dis ;189(10): Eron JJ, Feinberg J, Kessler HA, Horowitz HW, Witt MD, et al. Once-Daily vs. Twice- Daily Lopinavir/Ritonavir in Antiretroviral-Naïve HIV+ Patients: 48-Week Follow-up. J Infect Dis 189(2) 2004: Eron JJ, Gulick RM, Bartlett JA, Merigan T, Arduino R, Kilby JM, et al. Short-Term Safety and Antiretroviral Activity of T-1249, a Second-Generation Fusion Inhibitor of HIV. J Infect Dis : Corbett AH, Eron JJ, Fiscus SA, Rezk NL, Kashuba AD. The Pharmacokinetics, Safety, and Initial Virologic Response of a Triple-Protease Inhibitor Salvage Regimen Containing Amprenavir, Saquinavir, and Ritonavir. JAIDS 2004 Aug 1;36(4): Lim ML, Min SS, Eron JJ, Bertz R, Robinson M, et al. Co-Administration of Lopinavir/Ritonavir and Phenytoin Results in a Two-way Drug Interaction Through Cytochrome P-450 Induction.JAIDS 36(5) 2004: Wood R, Eron JJ, Arasteh K, Teofilo E, Trepo C, et al A 42-Week Open-Label Study to Assess the Pharmacokinetics, Antiretroviral Activity, and Safety of Amprenavir or Amprenavir + Ritonavir in Combination with Abacavir and Lamivudine for Treatment of HIV-Infected Patients Brief Clin Infect Dis 39(4) 2004: 591-4

3 Frank I, Bosch R, Fiscus SA, Valentine F, et al, Eron JJ, for the ACTG 307 Study Team. Activity, Safety, and Immunologic Effects of Hydroxyurea 1000 mg and 1500 mg Added to Didanosine in Antiretroviral Naïve and Experienced HIV-1 Infected Subjects. AIDS Res Hum Retroviruses 2004 ; 20(9): Ritola K, Pilcher CD, Fiscus SA, Hoffman NG, et al, Eron JJ. Multiple V1/V2 env variants are frequently present during primary infection with human immunodeficiency virus type1. JVirol Oct;78(20): Acosta EP, Wu H, Hammer SM, Yu S, Kuritzkes DR, Walawander A, Eron JJ, et al.; for the Adult AIDS Clinical Trials Group 5055 Protocol Team. Comparison of Two Indinavir/Ritonavir Regimens in the Treatment of HIV- Infected Individuals. J AIDS 2004 Nov 1;37(3): Eron JJ Jr, Bartlett JA, Santana JL, Bellos NC, Johnson J, et al. Persistent Antiretroviral Activity of Nucleoside Analogues After Prolonged Zidovudine and Lamivudine Therapy as Demonstrated by Rapid Loss of Activity After Discontinuation. JAIDS 2004 Dec 15;37(5): C. Research Support Federally Supported Research Projects 5 M01 RR Orringer (PI) 12/01/02-11/30/07 General Clinical Research Center Associate Director To serve as an institutional resource where health professionals of all types can receive training to conduct clinical research, to facilitate the rapid translation of advances in basic scientific knowledge into new or improved methods for patient care, and to provide a facility where the cause and the natural history of human illness can be defined and where disease progression, prevention, control, and cure can be studied. 3-U01-AI S2 Eron (PI) 04/01/05-12/31/06 /NIAID UNC Aids Clinical Trials Unit Co-P.I , P.I Present Originally Funded 09/01/87 The major goals of this project are to provide an effective and efficient system to evaluate the safety and efficacy of the therapeutic interventions against HIV infection, AIDS, and its associated conditions. 5 P30 AI Swanstrom (PI) 06/01/06-05/31/11 /NIAID Center for AIDS Research (CFAR) Clinical Core Director Facilitate and coordinate HIV translational research for basic scientists and clinical investigators. The Clinical Core promotes the development of new areas of HIV research by supporting new and experienced investigators. 5 U01 AI Haynes, PI 10/01/05-006/30/12 Center for HIV/AIDS Vaccine Initiative (CHAVI) Subcontract with Duke University, prime grantee. UNC will participate in a multi-center effort to develop new HIV vaccine strategy. UNC faculty in Lilongwe, Malawi, and on the UNC campus will conduct clinical observational studies designed to detect patients with acute HIV infection and to enroll such subjects in an observational cohort (Domestic Unit of Core B). UO1 AI41530 Pilcher, site PI 7/01/05-06/30/07 NIAID/ AIEDRP This subcontract to UAB s AIEDRP main grant (Kilby, PI) will support the recruitment and retention of acutely HIV infected patients to AIEDRP-funded research studies

4 AACTG.45.IICTU.07 Eron, PI 12/01/02-12/31/06 Social and Scientific Systems International Adult AIDS Clinical Trials Unit-Technical Assistance Project Technical assistance and capacity building project for the conduct of Adult AIDS Clinical Trials Group studies A5175, A5208 and A5199 in Lilongwe, Malawi. Pending RO1 Ahuja (PI) 12/01/06 11/30/11 Chemokine Systems and Prognosis in HIV Disease and Outcome of Therapy A pending application. Using the AACTG ALLRT cohort (HIV-1 infected individuals enrolled in a longitudinal observational study on HAART era) to probe the relationship between host genotype and prognosis of HIV-1 disease and outcome to antiretroviral therapies. Non-Federally Sponsored Research Projects PA Eron (PI) 11/01/04-10/31/06 Panacos Pharmaceuticals Phase IIA Proof of Principle Study evaluating antiretroviral activity of a novel assembly inhibitor. GSK ESS (KLEAN) Eron (PI) 02/24/04-02/23/06 (Ongoing) GlaxoSmithKline GW433908, Combivir, Epivir, ABC/3TC, Kaletra, RTV Phase III Study comparing fos-amprenavir / lopinavir / ritonavir both given with abacavir / lamivudine in HIV+ treatment naïve subjects. 03-MED-322 Eron (PI) 3/01/04-3/01/06 Boehringer-Ingelheim BI Tipranavir Open Label Tipranavir + Ritonavir Trimeris Pharmaceuticals Protocol T Eron (PI) 03/10/99-Ongoing A Phase 2 Evaluation of The Safety, and Antiviral Activity of T-20 Administered to HIV-1 Positive Adults by Subcutaneous Injection in Combination with Oral Antiretrovirals. Protocol T Eron (PI) 03/10/99-Ongoing A Rollover Study of T-20 Administered in Combination with a Background Antiviral regimen in HIV-1 Positive Adults Who Have Completed Clinical Trial T Protocol T Eron (PI) 02/09/01-5/31/05 (Ongoing) Phase III clinical trail with comparing T20-301/Ro in combination with OB therapy (based on the patient s prior history and genotypic/phenotypic resistance testing), to the OB therapy alone, in patients who have failed the currently available classes of antiretrovirals. Protocol M Eron (PI) 11/19/02-03/01/06 Abbott Laboratories, Inc. LPV/r + INV v LPV/r + Combivir Completed Non-Federally Sponsored Research Projects Abbott Laboratories, Inc. Protocol M Eron (PI) 12/19/02-12/18/04 A Phase I/II Study of ABT-378/Ritonavir in Combination with Reverse Transcriptase Inhibitors in ARV Naïve HIV+ Patients. Protocol M Eron (PI) 01/05/01 01/04/04

5 Safety, tolerability and pharmacokinetics of high dose ABT-378/r and ABT-378/r with ritonavir. Antiretroviral activity ABT-378/r and ABT-378/r with ritonavir. Protocol 035 Eron (PI) 05/01/95 06/30/04 Merck Research Laboratories A Multicenter, Double-Blind, Randomized, One-Year Study to Evaluate the Safety and Activity of MK-639 Administered in Combination With Zidovudine and 3TC Versus Zidovudine and 3TC Versus MK-639 Monotherapy for the Treatment of HIV Infection. 2 P01 AI Johnston (PI) 09/28/01-06/30/06 Therapeutic Vaccination for HIV Using VEE Vectors Co-Primary Investigator The program project will initially design, construct and produce a VEE vectored HIV clade B vaccine to be used in a therapeutic Phase I/II trial in HIV-infected HAART-treated individuals. Concurrently, the Program will develop improved therapeutic vaccine modalities for subsequent trial in humans.